NCT02812160

Spatz Adjustable Balloon for Obesity (SABO)

A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Spatz FGIA, Inc · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.

Detailed description

Device Name: Spatz3 Adjustable Balloon System® (Spatz3) Clinical Phase: Pivotal Trial Design: Multicenter open-label randomized controlled trial Trial Participants: Adults, ages 22-65, with a BMI ≥ 30 and \< 40 who have failed to achieve and maintain weight-loss with a weight control program Control group: Supervised diet and exercise Planned sample size: 282 subjects randomized 2:1 to device/control study treatment duration: 32 weeks Primary endpoint: Percent change in total body weight (%TBL) at 32 weeks

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Spatz3 Adjustable Balloon	An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed

Timeline

• Start date: 2016-09-12
• Primary completion: 2018-10-01
• Completion: 2019-01-01
• First posted: 2016-06-24
• Last updated: 2021-05-28
• Results posted: 2021-05-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study